MORTALITY AND MORBIDITY IN HEMODIALYSIS STUDY PROTOCOL

血液透析研究方案中的死亡率和发病率

• 批准号: 2149932
• 负责人: William F Owen
• 金额: $ 20.14万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-30 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2149932
• 关键词: biomaterial evaluation; blood chemistry; cardiovascular disorder; chronic renal failure; clinical trials; cooperative study; hemodialysis; human morbidity; human mortality; human subject; human therapy evaluation; infection; medical complication; nutrition; serum albumin; urinalysis

The approximate 24% annual gross mortality of US hemodialysis patients is unacceptably high. The precise reason for this variance in mortality may relate to the quantity of dialysis delivered. The definition of adequate dialysis derived from the NCDS is inapplicable to today's older patients with more co-morbidity, and to current dialysis conditions in which dialyzer reuse is prevalent. The conventional methods for calculating the critical variable, the total urea clearance per dialysis normalized for urea's distribution volume (KT/V), may be inadequate in its assumption of a single pool of distribution. The influence of the more costly, but biocompatable, high flux dialyzers is unresolved. Lastly, the impact of rigorous monitoring of dialysis delivery and the practice of standards for general medical care on patient survival, morbidity, rehabilitation, and compliance is unknown. Because of these critical deficiencies in the knowledge for the care of Americans with ESRD, we propose to serve as a "Clinical Center" in cooperative agreement with the MDDK and with other approved Centers in the full-scale phase of the Mortality and Morbidity in Hemodialysis Patients Trial as defined in the "Study Protocol" of 12/23/93. In this prospective, multicenter, randomized, two-by-two factorial trial, we propose that a high delivered KT/V and (or) dialysis with a biocompatable, high flux membrane material will reduce patient mortality and morbidity. The interventions are: (1) the KT/V as calculated by a two pool volume of distribution formulation, and (2) the concurrent dialyzer flux for large molecular weight solutes and its biocompatability. For the KT/V component, the target values of 1.4 (range of 1.3 to 1.5) and 1.0 (0.9 to 1.1) will be calculated by either the Smye method, the Baxter or Fresenius Dialysis Sampler method, or the 30 minute rebound method. The other variable will be the flux capacity and the biocompatability of the dialysis membrane, based upon a functional definitions of the beta2-MG sieving coefficient, and intradialytic neutropenia and complement generation. respectively. The primary outcome will be the patients' death rate, and the secondary outcomes will be the hospitalization rate and frequency for non-access related problems, cardiac disease, and infections, and a decline in the serum albumin concentration. We will be responsible for the timely retrieval of the appropriate blood samples, the administration and retrieval of questionnaires, monitoring the clinical status of the patients and maintaining their health, documenting that the protocol is being strictly adhered to by the patients and the dialysis facilities, replacing patients that die or who drop out of the study, transmitting the appropriate blood and urine samples to the Central Biochemistry Laboratory and the test results and information to the DCC, monitoring local quality control, and participating in all conjoined Center and Committee activities.

美国血液透析患者的年总死亡率约为 24% 高得令人无法接受。死亡率差异的确切原因可能是 与进行的透析量有关。充足的定义 源自 NCDS 的透析不适用于当今的老年患者 具有更多的合并症，以及目前的透析条件 透析器重复使用很普遍。传统的计算方法 关键变量，每次透析的总尿素清除率标准化为 尿素的分布体积（KT/V），其假设可能不充分 单一分配池。影响的代价更大，但是 生物相容性高通量透析器尚未解决。最后，影响 严格监控透析输送和实施标准 关于患者生存、发病、康复和康复的一般医疗护理 合规性未知。由于这些关键缺陷 为了照顾患有终末期肾病 (ESRD) 的美国人，我们建议充当 与 MDDK 及其他机构签订合作协议的“临床中心” 批准中心处于死亡率和发病率全面阶段 血液透析患者试验的“研究方案”中定义 93 年 12 月 23 日。在这项前瞻性、多中心、随机、两两 析因试验中，我们建议采用高 KT/V 和（或）透析 使用生物相容性高通量膜材料将减少患者 死亡率和发病率。干预措施是： (1) 通过两池分布体积计算的 KT/V 配方，以及（2）大分子的并发透析器通量 溶质重量及其生物相容性。对于 KT/V 分量， 目标值为 1.4（范围为 1.3 至 1.5）和 1.0（范围为 0.9 至 1.1） 通过 Smye 方法、Baxter 或 Fresenius 透析计算 采样器法，或30分钟回弹法。另一个变量将 是透析膜的通量和生物相容性， 基于 beta2-MG 筛分系数的函数定义， 以及透析中中性粒细胞减少症和补体生成。分别。这 主要结局是患者的死亡率，次要结局是 结果将是住院率和无法进入的频率 相关问题、心脏病和感染，以及 血清白蛋白浓度。我们将负责及时 获取适当的血液样本、给药和 检索问卷，监测患者的临床状况 患者并维护他们的健康，记录该协议是 患者和透析机构严格遵守， 替换死亡或退出研究的患者，传播 将适当的血液和尿液样本送往中央生化实验室 并将测试结果和信息发送给DCC，监控本地质量 控制并参与所有联合中心和委员会 活动。